FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® HOLTER®
DI: 10381780515531
·
Model: 821695
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- CODMAN® HOLTER®
- Primary DI
- 10381780515531
- Version / Model
- 821695
- Catalog Number
- 82-1695
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-06-02
- Public Version
- 6
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- f6d2ccdc-6a73-4e19-bedd-664aeaa61d5b
Device Description
CODMAN® HOLTER® Type B Fixation and Joining Connector Straight
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47515 | Cerebrospinal fluid shunt connector | An implantable device intended to create a fluid path connection between components of a cerebrospinal fluid (CSF) shunt assembly (e.g., lumbar and/or peritoneal catheters of a ventriculoperitoneal or lumboperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is available in various designs (L-, Y- or cross-shaped, straight). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00381780515534 | GS1 | ||||
| Previous | 10886704040743 | GS1 | ||||
| Primary | 10381780515531 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Use if Package is Damaged